Lidgrer-Lund Acetabular Sockets
510(k) K852369
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852369 | Date18 Jun 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Lidgren-Lund Acetabular Sockets are semi-constrained metal cemented acetabular components designed for hip arthroplasty. These devices are intended to replace the damaged acetabulum, providing a stable bearing surface for the femoral head prosthesis to articulate with, thereby restoring hip joint function and mobility.
These sockets are supplied as reusable medical devices and are intended for use in orthopedic surgical settings. They are classified as Class III devices under FDA regulations and require cement fixation for implantation. The components are available in multiple sizes as referenced by the listed FEI numbers and are regulated under the regulation number 888.3320. No specific MRI safety information is provided in the data.
Other devices from Link America, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these acetabular sockets designed for single-use or can they be reused in multiple procedures?
The Lidgren-Lund Acetabular Sockets are explicitly labeled as reusable medical devices for use in orthopedic surgical settings. This classification means they are intended to be sterilized and reused after proper cleaning and reprocessing, rather than being discarded after a single use.
What sizes are available for the Lidgren-Lund Acetabular Sockets, and how are they identified?
The sockets come in multiple sizes, each identified by a unique FEI number (e.g., 3020282716, 3007923096, etc.). These numbers correspond to specific acetabular dimensions to ensure proper fit during hip arthroplasty. The full list of FEI numbers is available in the regulatory data under the product code JDL and regulation 888.3320.
How are these sockets implanted, and what role does cement play in their use?
The Lidgren-Lund Acetabular Sockets are cemented acetabular components, meaning they require bone cement fixation for secure implantation during hip arthroplasty. The cement provides stability by bonding the socket to the patient’s pelvis, ensuring long-term integration and load-bearing capacity.
Are there any special storage requirements for these reusable acetabular sockets?
While the data does not specify exact storage conditions, reusable medical devices like these typically require sterilization and proper packaging to prevent contamination between uses. They should be stored in a clean, dry environment, following manufacturer guidelines for reprocessing and shelf-life to maintain safety and functionality.